Hospi Corporation’s first product, the Macy Catheter, is a simple and innovative medical device designed to facilitate discreet and comfortable rectal administration of medications. Rectal administration is a proven route of delivery and can be particularly relevant during serious or terminal illness, or in any situation where the oral route of administration is compromised. The Macy Catheter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now available commercially in the United States. NCC-PDI was contacted to explore the feasibility of creating a pediatric version of this device.
Year:
2016
Anticipated Classification:
Class I Exempt
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Manufacturing
Current Development Stage:
Manufacturing
